Z-0944-2022Class I

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Name: Z-0944-2022 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Creator: SML Distribution, LLC
Published: 2022-03-04
License: https://open.fda.gov/license/

SML Distribution, LLC / initiated 2022-03-04 / Open, Classified

FDA source

SML Distribution, LLC began a recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test on 2022-03-04. FDA classified it as Class I and gives the reason as "The product was distributed without FDA authorization or clearance for marketing and distribution in the US". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0944-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-03-04
Posted: 2022-05-03
Recalling firm: SML Distribution, LLC
Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
FDA root cause: No Marketing Application
Action: The firm initially contacted affected customers by phone between March 4 and March 12, 2022. On March 21, 2022, the firm followed up with emails to each affected distributor with subject line "IMPORTANT!!! Recall Notice" which included a recall letter attachment. Customers were asked to immediately return all unused product. The firm sent an additional email on March 25, 2022 which instructed customers to not rely on the recalled tests to make medical decisions. As of April 9, 2022, the full recall notice can be found at www.smldistribution.com.
Quantity in commerce: 209,450 units
Distribution: US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.
Product codes and lots: All lots: UL-AG-2110-05-Q UL-AG-2111-02-Q UL-AG-2112-01-Q UL-AG-2112-02-Q UL-AG-2201-03-Q

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0944-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0944-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-05-03

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)